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Collagen Matrix, Inc. recalls RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Recalled March 2, 2022 · FDA recall Z-0669-2022 · Collagen Matrix
Hazard
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery · FDA Class II
Units
10 units
Sold at
DuraMatrix-Onlay distributed US Nationwide in the states of FL, IN, Puerto Rico, and the countries of Canada, Chile, and Colombia. RESODURA matrix onlay distributed in Germany.
Description
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Product
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Manufacturer(s)
Collagen Matrix, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →